LH-75 PHOTOTHERAPY SYSTEM

K091568 · Lerner Medical Devices, Inc. · FTC · Nov 5, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K091568
• Device Name: LH-75 PHOTOTHERAPY SYSTEM
• Applicant: Lerner Medical Devices, Inc.
• Product Code: FTC · General, Plastic Surgery
• Decision Date: Nov 5, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LH-75 Phototherapy System is intended for use, by or under the direction of a physician, in UVB phototherapy for the treatment of psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis and leucoderma. The LH-75 Phototherapy System is intended for use on all skin types (I -VI).

Device Story

LH-75 Phototherapy System provides targeted UVB phototherapy for dermatologic conditions. Device emits ultraviolet radiation to treat skin disorders; operated by or under direction of physician in clinical setting. System delivers controlled UVB light to affected skin areas; intended to manage symptoms of psoriasis, vitiligo, eczema, seborrheic dermatitis, and leucoderma. Clinical benefit derived from therapeutic effects of UVB exposure on skin lesions. Physician determines treatment parameters; monitors patient response to therapy.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and intended use comparisons to legally marketed predicate devices.

Technological Characteristics

Ultraviolet lamp system for dermatologic disorders; utilizes UVB radiation for therapeutic treatment. Device is a Class II medical device (Product Code: FTC).

Indications for Use

Indicated for patients with psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis, and leucoderma across all skin types (I-VI).

Regulatory Classification

Identification

An ultraviolet lamp for dermatologic disorders is a device (including a fixture) intended to provide ultraviolet radiation of the body to photoactivate a drug in the treatment of a dermatologic disorder if the labeling of the drug intended for use with the device bears adequate directions for the device's use with that drug.

Predicate Devices

• TheraLight, Inc. UV1 20-2 UVA / UVB Phototherapy System (K022165, K024020)
• Lerner Medical Devices, Inc. LH-75T Phototherapy System (K090097)
• Daavlin Distributing Co. 3 Series Phototherapy Cabinet (K063621)
• Daavlin Distributing Co. Flex Controlled Phototherapy Equipment (K050695)

Submission Summary (Full Text)

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510(k) Summary

## NOV – 5 2009

This 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92.

| Date: | May 27, 2009 |
|-----------------------------|-----------------------------------------------------------------------------------------|
| Submitter's name: | Lerner Medical Devices, Inc. |
| Submitter's Address: | 1545 Sawtelle Ave. Suite 36<br>Los Angeles, CA 90025 |
| Submitter's Telephone: | [phone] |
| Submitter's Fax: | [phone] |
| Contact Person: | Zafirios F. Gourgouliatos, Ph.D.,<br>Chief Science Officer<br>Management Representative |
| Device Trade Name: | LH-75 Phototherapy System |
| Device Common Name: | Targeted UVB Phototherapy System |
| Device Classification Name: | Ultraviolet lamp for dermatologic / skin disorders |
| Regulation Number: | 878.4630 |
| Product Code: | FTC |
| Classification: | Device Class II |
| Establishment Reg. Number: | 3006793564 |
| List of Predicate Devices: | TheraLight, Inc.<br>UV1 20-2 UVA / UVB Phototherapy System<br>K022165, K024020, |
| | Lerner Medical Devices, Inc.<br>LH-75T Phototherapy System<br>K090097 |
| | Daavlin Distributing Co.<br>3 Series Phototherapy Cabinet<br>K063621 |
| | Daavlin Distributing Co.<br>Flex Controlled Phototherapy Equipment<br>K050695 |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

NOV - 5 2009

Lemer Medical Devices, Inc. % Zafirios Gourgouliatos, Ph.D. Chief Science Officer and Management Representative 1545 Sawtelle Boulevard. Suite 36 Los Angeles, California 90025

Re: K091568

Trade/Device Name: LH-75 Phototherapy System Regulation Number: 21 CFR 878.4630 Regulation Name: Ultraviolet lamp for dermatologic disorders Regulatory Class: Class II Product Code: FTC Dated: October 23, 2009 Received: November 02, 2009

Dear Dr. Gourgouliatos:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing

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Page 2 - Zafirios Gourgouliatos, Ph.D.

(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

For

Mark N. Mello

Mark N. Melker Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement

510(k) Number ________________________________________________________________________________________________________________________________________________________________

Device Name: LH-75 Phototherapy System

The LH-75 Phototherapy System is intended for use, by or under the direction of a physician, in UVB phototherapy for the treatment of psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis and leucoderma.

The LH-75 Phototherapy System is intended for use on all skin types (I -VI).

X O OR Over-the-Counter Use __________________________________________________________________________________________________________________________________________________ Prescription Use __________ (per 21 CFR 801.109)

(Please do not write below this line - Continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

MichRP. Ogle frc sxm

(Division Sign-C Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K091568